Predictors of Neuro-cognitive Decline and Survival in HIV-infected Subjects

Official Title ICMJE

Not Provided

Brief Summary

Patients will be followed every 6 months for a total of 5 visits (Month 0, 6, 12, 18 and 24). The first visit is the screening and entry visit which can occur at any time after the subject finishes SEARCH 001 study but preferably it should occur approximately 6 months after SEARCH 001 study completion.

At each visit, patients will undergo the following

Assessment of function including activity of daily living questionnaire

History of medical illnesses, medication history

Neurological examination: All patients will have a neurological evaluation and neuropsychological evaluation to characterize neurocognitive and neurological status. (It is possible that patients within the non-dementia group will meet criteria for dementia after close testing is completed).

Neuropsychological assessment:

Thai Depression Inventory.

HIV viral load and storage of blood for proviral DNA level

Final outcome assessment based on all available data. If possible, it is intended that these diagnoses will be determined through monthly VTC conference calls with UH investigators. This consensus conference will include the Thai investigators, the UH neurologist, the UH neuropsychologist and the UH principal investigators.

Detailed Description

Not Provided

Study Type ICMJE

Observational

Study Design ICMJE

Observational Model: Case ControlTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Condition ICMJE

AIDS

Dementia

Intervention ICMJE

Not Provided

Study Group/Cohort (s)

HIV-infected, no dementia

Patients with HIV-infection but no dementia

HIV-infected, dementia

Patients with HIV-infection and dementia

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

60

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

All patients who have completed the SEARCH 001 study are eligible to enroll in this SEARCH 001.1 study provided that they understand and voluntarily sign the informed consent form.

Exclusion Criteria:

Gender

Both

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects